Are you importing sunglasses or eyewear into the European Union? Sunglasses and eyewear are considered to be personal protective equipment, and therefore are subject to the Personal Protective Equipment (PPE) Regulation.
Besides this, sunglasses and eyewear are subject to different regulations and standards to ensure the safety of the wearer, such as the REACH regulation.
Content Overview
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Personal Protective Equipment (PPE) Regulation
Sunglasses and eyewear are categorized as personal protective equipment. As such, before placing these products on the EU market, it is mandatory to ensure compliance with the Personal Protective Equipment Regulation.
Product scope
The Personal Protective Equipment Regulation covers many types of PPE, including eyewear.
We list below several types of sunglasses and eyewear covered by the regulation:
- Sunglasses with sun glare filters
- Sun glare filter for direct observation of the sun
- Swim goggles
- Ski goggles
- Googles for motorcycle use
- Goggles for snowmobile use
PPE risk categories
PPE products are divided into three categories.
Category I:
It includes PPE products that are intended to protect users from minimal risks, such as:
- Sunglasses
- Eye protectors for dust protection
Category II
It includes risks other than those listed in Categories I and III.
Category III
It includes PPE products that protect from risks that may cause serious consequences such as death or irreversible damage to health. For example
- Eye protectors for use at high temperatures
- Eye protectors for use at extremely intensive IR radiation
Harmonised standards
Harmonised standards provide a presumption of conformity with the technical requirements of the regulations. Here are some standards relevant for sunglasses and other protective eyewear that are harmonised under the PPE Regulation:
a. EN ISO 12312 -1 – Eye and face protection – Sunglasses and related eyewear – Part 1: Sunglasses for general use
b. EN ISO 12312-2 – Eye and face protection – Sunglasses and related eyewear – Part 2: Filters for direct observation of the sun
c. EN 172 – Personal eye protection – Sunglare filters for industrial use
d. EN 174 – Personal eye-protection – Ski goggles for downhill skiing
e. EN 175 – Personal protection – Equipment for eye and face protection during welding and allied processes
You can learn more about harmonised standards in this guide.
Declaration of Conformity
Importers and manufacturers of PPE products are responsible for drafting the EU Declaration of Conformity, to declare that the eyewear product complies with the PPE Regulation. The following information should be included:
- Product type, batch, or serial number
- Company name and address
- Reference to relevant harmonised standards
- Notified Body information (if necessary)
Technical file
The technical documentation should be included, in addition to the DoC. It should include information such as:
a. A complete description of the PPE and of its intended use
b. Design drawings and schemes of the PPE
c. Inspection and examinations report that were carried out to verify the conformity of the PPE
d. Copy of the user instructions
Notices that it is not necessary to provide the technical documentation to the buyers. Importers and manufacturers are only responsible to share the technical file if requested by the relevant authorities.
CE Marking
By affixing the CE marking to a product, the manufacturer implies that the product complies with the requirements of all applicable CE marking directives and regulations.
The importer or manufacturer should affix the CE marking on the product (e.g. the internal part of the sunglasses frame) and the packaging.
Other labelling requirements
Importers and manufacturers are required to ensure that their products can be traced by consumers and relevant authorities.
According to Article 8 “Obligations of manufacturers” of the PPE Regulation, you are required to place the following information onto your products (or onto their packaging, or accompanying document):
- Identification type
- Batch or serial number
- Name, registered trade name, or registered trademark
- Postal address
The above information must be clearly printed in a language that end-users, as well as market surveillance authorities, can easily understand.
Notified body
PPE that is classified as Category II and III has to undergo a conformity assessment performed by a notified body.
A notified body is an organization designated by a country in the EU to assess whether certain products conform to relevant technical requirements and are safe to use, before they are placed on the market.
In particular, the notified body performs an EU type-examination by assessing the technical design of the product and verifying that it conforms to the requirements of the regulation.
The EU type-examination procedure is summarized as follows:
1. The importer or manufacturer applies for an EU type-examination
2. The notified body conducts the EU type-examination
3. The notified body produces an evaluation report and an EU type-examination certificate
Notified body identification number
Additionally, for products that are classified under category III, the CE marking should be followed by the identification number of the notified body that performed the procedure set in Annex VII or Annex VIII of the directive.
The CE marking might also be followed by a pictogram that represents the risks for which the PPE is designed to protect the user.
Lab testing
Lab testing is often the only way to ensure that your product complies with relevant requirements. The tests depend on the product and might concern:
- Impact resistance testing
- Chemical testing
- Biological resistance testing
- Fall arrest equipment testing
Here we listed several laboratories that can help with the PPE testing:
- Intertek
- TÜV SÜD
- Satra
- Testex
REACH
REACH is a regulation that prevents excessive amounts of harmful chemicals from entering the environment and causing health issues. Chemicals restricted under REACH can be found in many everyday items, such as plastic eyewear frames and lenses.
Product scope
The REACH regulation was put in place to prevent chemicals and articles containing chemicals from causing health and environment-related risks as much as possible.
REACH applies to most consumer products, such as:
- Eyewear
- Plastic sunglass frames
- Coated eyewear metal frames
Restricted substances
Eyewear, including sunglasses, may contain plastic, coatings, and other materials that may contain several REACH-restricted substances. They include:
- Phthalates
- Lead
- Cadmium
For example, under Annex XVII of REACH, the amount of certain phthalates should not exceed 0.1% in total weight. This includes the following:
- DEHP
- DBP
- BBP
- DIBP
Lab testing
Importers and manufacturers are responsible for ensuring their products, including eyewear, can be sold and safely used by consumers. As such, it is important that they send their products for testing to make sure that their products do not contain any REACH-restricted substances above the prescribed limits.
Packaging & Packaging Waste Directive
The Packaging & Packaging Waste Directive aims at enforcing rules on managing not just packaging design but also packaging waste. Their overarching idea is to cut down on packaging waste as much as possible, and when unavoidable, help implement ways to collect and recycle it. The directive also sets restrictions on the amount of heavy metals that might be contained in packaging materials.
The directive aims to:
a. Harmonize national measures related to packaging and managing packaging waste
b. Provide protection of the environment on as high a level as possible, including setting limits for heavy metals
c. Prevent packaging waste from being produced
d. Promote recycling, reusing, and recovering of packaging waste instead of letting it be simply thrown away.
Product scope
The Packaging and Packaging Waste directive covers all kinds of packaging, including packaging for eyewear made on:
- Paper
- Plastic
- Other materials
Substance restrictions
Article 11 of the Packaging and Packaging Waste Directive states that members of the EU have to make sure that heavy metals (lead, cadmium, mercury, and hexavalent chromium) in the packaging or its components do not exceed specified levels.
We list the levels to which the aforementioned heavy metals are restricted, below:
- Lead < 0.01% by weight
- Cadmium < 0.01% by weight
- Mercury < 0.01% by weight
- Hexavalent Chromium < 0.01% by weight
Recycling targets
The Packaging and Packaging Waste Directive also aims to meet recycling targets of various recyclable materials by 2025 and 2030, respectively. We list them below.
| 2025 Targets | 2030 Targets | |
| All packaging | 65% | 70% |
| Plastic | 50% | 55% |
| Wood | 25% | 30% |
| Ferrous metals | 70% | 80% |
| Aluminum | 50% | 60% |
| Glass | 70% | 75% |
| Paper and cardboard | 75% | 85% |
Extended Producer Responsibility (EPR)
The Packaging and Packaging Waste Directive has set EPR requirements that EU members have to comply with before December 2024.
Extended Producer Responsibility (EPR) is a type of policy that makes importers and manufacturers responsible for what happens to a product after it reaches the consumers.
For example, if a consumer decides to discard the packaging of his or her sunglasses, under the EPR framework importers and manufacturers are responsible for collecting and recycling it.
In order to do so, companies can sign an agreement with an EPR organization (e.g. Der Grüne Punkt in Germany), and pay a fee to the organization, which will then collect, dispose and recycle the packaging on behalf of the company.
FAQ
Who is responsible for ensuring compliance if the sunglasses are imported from outside the European Union?
While the PPE directive often refers to the manufacturer, the importer is considered the ‘legal manufacturer’ if the goods are imported from outside the EU. For example, if you import sunglasses or other eyewear from China, it’s up to you to implement the compliance process:
1. Book lab testing
2. Create label files
3. Create the Declaration of Conformity (DoC)
4. Create the technical file
Importing and selling non-compliant sunglasses and other eyewear is illegal, and can result in the goods being confiscated by the customs authorities, or subject to a recall by national market surveillance authorities.
How do I ensure that the sunglasses lenses are PPE compliant?
We recommend that you purchase PPE compliant lenses from established brands, such as Carl Zeiss. European and American lens brands are widely available in China and other manufacturing countries – making it easy for you or your supplier to procure compliant lenses.
The other alternative is to procure Noname lenses from smaller OEM factories. That said, such suppliers can rarely provide test reports, which therefore requires that you book and pay for the necessary lab tests.
Further, far from all lenses are made to comply with the PPE directive.
Is the PPE a CE Marking Regulation?
Yes, the Personal Protective Equipment (PPE) Regulation is a CE Marking Regulation.
If a company was looking at importing 4 different frame styles but with only 2 different lens options would I require certification for every separate model or would they be able to be grouped by lens type instead?
hi Ash,
If they are different designs, then they would be treated as separate models although the lenses are similar, hence you will need to test all 4 frame styles, but if they are similar designs with colour of the frame difference then, they could be tested as 1 model. I hope this make sense
thanks
If your sunglasses are under category 1 of PPE, does EU regulation require lab certification or would self-declaration suffice provided the sunglasses standards EN ISO 12312-1 and PPE regulation(EU) 2016/425- which is what’s documented on the self-conformity.
Hello.
What related U.K. and EU regulations apply to sunglasses?
Hi Glenn
The regulation is called PPE Regulation 2016/425 applied to sunglasses.
thanks
Hi
I have a question on Sunglasses, we are a baby/children’s wear
We are currently look at doing sunglasses for 0-3 yrs but as a toy,
SO what labelling would we need and testing?
Thank you
Rav
Hi Mark,
I have a question on Sunglasses, we are a baby/children’s wear
We are currently look at doing sunglasses for 0-3 yrs but as a toy,
SO what labelling would we need and testing?
Hello,
Is it legal to sell distance glasses (prescription) online on the EU market (FR, IT, ES and UK) in particular? I read that it is illegal to do so in France?
If so, are there any disclaimers required?
Also, is legal to sell online in the US – disclaimers?
Which EU and UK regulations on glasses specify this information?
Your feedback will be greatly appreciated!
Thank you.
HI There,
I have a question about the sunglass directive leaflet that comes in all languages of the countries that you sell in. Currently our leaflet is approximately 70 pages and costs a lot off the bottom line. Do you know if you can use a 1-2 page leaflet with a QR code for all of the languages?
Cheers,
Cindy
Hi – Do sunglasses require a UPC number in the US and/or an EAN number in the EU?
Hi there,
I wanted to ask if I have multiple listings with the same type of glasses. Like different colours and quantities but essentially 2 different designs, do I only need a CE mark for the 2 designs?
Hi Joe,
Are these glasses made using the same lenses and materials? I think that is the most important factor here.
Hi there,
Do blue light glasses fall under ppe? Also is it the frame & lenses that are tested for the material or the transmittance of light through the lens? Can SGS test for this in China and provide the technical documentation?
What would the reach certification require for this?
Also for a small alkaline button battery is there any additional work that needs to be done with regards to ce certification? Or does it just need the MSDS and to be packaged well?
Many thanks
Hi
Would selling second hand ray ban sunglasses require me to provide additional documentation relating to testing that the manufacturer had already done for the PPE CE classification?
Or is the CE mark enough for a customs official to be satisfied.
Selling from EU to U.K. and U.K. to rest of the world.
Thanks for your help.
Hi Michael,
It is possible that they will require a DoC and possibly even a test report.
Hi Fredrik,
I need help setting up an RSL and a test program to make sure (Restricted Substances List) factory and producer comply with EU legislation on chemicals.
Do you have a suggestion how to do these best or and example you would use to be sure of these.
Hello AG,
Do I get this right?
1. You want to create a list of regulated substances (and probably also the limits)
2. You want to verify if the products are compliant (this can be verified through lab testing – either on the final product or the different materials and coatings)
Yes correct,
I want to make a RSL list, and plan fo how wee control it in the future – like a document to the factory so they know what we expect from them, and also so our retailers can see what they can expect us (also a demand from bigger retailers). To make sure we have REACH and european and US standard on all products.
But as I’m not Chemist, so I dont know how to make it and not sure what should be in it or where I could find these or get help to get it made.
But surely not the only one, struggling here :-D
Hi AG,
In that case I suggest you contact a lab and ask them to:
1. Provide a list of substance tests (this is part of the standard qutoation)
2. Arrange a lab test with them
You can request a free quote here: https://www.compliancegate.com/lab-testing/
Hi there,
Awesome article and great job with the community.
Do sunglasses need to mandatorily contain place pf manufacture (ex. Made in China) directly on the sunglasses? Because i see alot of models from other brands that dont have. Or is that just for US.
Thanks
Hi Daniel,
Country of origin labeling is mandatory in the USA, not EU
Hello, I make sunglasses by hand using acetate, hinges & lenses sourced from Italy, currently I have a very low production rate making these very exclusive, about 5 glasses made per different design, I’m wondering if I need to test every new model I come up with or if I can stay in business without getting into any sort of trouble..
Your post has been very well written and informative, thank you!
Hi Victor,
Well, technically you’d still need to arrange the DoC and other documentation, but it’s possible that you could use test reports from the material supplier in Italy (which is in the EU)
Hello Mark,
I am importing sunglass clip-on glasses which will have only demo lenses (no prescription). If I understand correctly, there are going to be under the PPE since they are not prescription, and are sunglasses as well. Is this right?
In this case the asian manufactured have the “Attestation Certificate for Medical Device Safety”, which this certification allow me to distribute the sunglass clip-on glasses in EU? Thus not being blocked by the custums?
Thank you, Riccardo
Hi Riccardo,
Attestation Certificate for Medical Device Safety sounds like a bogus “certificate”. Plenty of those going around these days, but there are no workarounds when it comes to CE.
We have imported sunglasses without the CE Mark. The manufacturer claims that the sunglasses PPE are compliant. The goods are held at customs. What are our options? Can we follow the compliance process locally including lab testing? Or is it specific labs appointed by the EU which perform the tests?
Hello,
As the customs if they will accept that you’ll re-label the sunglasses in Europe. Not sure if they accept that though.
Also, if the sunglasses are truly compliant then the supplier can also provide a lab test report and DoC.
Hello, do hay fever glasses fall into PPE and need CE marking?
Hi, how can I find out of a testing lab can release CE certificates of conformity?
Hi Lucio,
Are you referring to a Notified Body?
Find them here: List of bodies notified under Regulation (EU) 2016/425 on personal protective equipment (NANDO information system)
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501
if you are looking for a lab which can test sunglasses or other eyewear products , you can contact Spectroplus Ltd located in UK which conduct testing on resonable prices.
Hello, what about sunglasses specifically marketed at children, are these also considered PPE?
Thanks!
Hi Tom,
Yes, I cannot imagine that the requirements are lower for children’s sunglasses. If anything it’s the opposite.
Am I correct understanding that *any* kind of eyewear, even fashion items or generally items that are not intended for professional use and don’t claim any protective properties per se, you know, tinted shades and such, are treated as PPE and shall therefore meet all these standards? What about 3D glasses in cinemas?
Hi Marvin,
Sunglasses are covered by PPE. That said, not sure applies to 3D cinema glasses. Probably not classified as PPE.
What are the regulations for non PPE sunglasses?
Hello Mark, what do you mean with “non PPE” sunglasses? Could you explain it a bit more in detail?